Two health organizations on Tuesday requested FDA reverse its position that a popular anti-aging ingredient, NMN, is excluded from the definition of a dietary supplement.
In a 12-page citizen petition, the Alliance for Natural Health USA (ANH) and Natural Products Association (NPA) asked that FDA make the determination above or “commit to exercise enforcement discretion in connection with the marketing and selling of NMN in or as a dietary supplement.”
Alternatively, NPA and ANH requested FDA find NMN is lawful in supplements by promulgating a regulation following notice and comment through the secretary of the U.S. Department of Health and Human Services (HHS).
The petition was filed about a week before a ban on the sale of NMN supplements on Amazon goes into effect.
On Nov. 10, 2022, Natural Products Insider broke the story regarding FDA’s determination that NMN could not be sold in supplements due to its investigation as a drug prior to its lawful marketing as a dietary supplement.
Industry representatives criticized FDA’s decision, pointing out its failure to raise the "drug preclusion" issue in its previous review of ingredient notifications to FDA that are required under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
On the other hand, FDA explained that when it made the connection between NMN and a drug authorized for investigation called MIB-626, it determined the substance could not be lawfully marketed as a supplement.
The citizen petition alleged FDA has misinterpreted and misapplied the relevant law as it relates to NMN.
For instance, NMN capsules were offered in Japan as early as 2016, according to ANH and NPA. The petitioners argued that FDA has no basis to assert a substance must be marketed in the U.S. in supplements under the race-to-market provision in the law that governs whether an article is excluded from a definition of a dietary supplement due to its investigation or approval as a drug.
“There is nothing in the plain language of the statute that requires the prior marketing of the article to only have occurred in the United States,” the petitioners wrote. “The FDA is improperly trying to import a limitation into the statute that does not exist.”
The petitioners also questioned FDA’s interpretation of when an article like NMN is “authorized for investigation.” FDA has found the criteria is met when an investigational new drug (IND) application takes effect, which is typically not made available to the public.
“This interpretation and application of the [Federal Food, Drug & Cosmetic Act] is troubling for at least two reasons: (1) INDs are not authorized by FDA; and (2) to petitioners’ knowledge, there is no public access to a database or list of current articles that are the subject of an IND,” the citizen petition asserted. “In fact, FDA’s regulations prevent it from publicly revealing the effective date of an IND or the source of the IND.”
ANH and NPA said they found it “perplexing” that FDA has determined Congress would establish “a regulatory race to market between those wishing to distribute/manufacture dietary ingredients/supplements and those investigating articles as drugs, but not intend for both sides to have access to the relevant date that would be absolutely necessary to make any determination as to the regulatory status concerning the marketability of the ingredient.”
Asked for comment on the petition, an FDA spokesperson said her agency is reviewing it and will respond directly to the petitioners.
This isn’t the first citizen petition trade organizations have filed in recent years, following a determination by FDA that an ingredient cannot be sold in dietary supplements due to its approval or investigation as a drug.
NPA filed a citizen petition concerning NAC (N-acetyl-L-cysteine), then later sued FDA. The agency ultimately adopted a policy of “enforcement discretion” in a final guidance released in the summer of 2022.
“FDA’s sudden and contradictory announcement relative to the regulatory status of NMN as a dietary ingredient that is excluded from the definition of a dietary supplement, along with the arbitrary, erroneous, unreasonable and inequitable interpretation of the Act it relied on, adversely affects the entire dietary supplement stakeholder community,” the petitioners concluded. “The current situation with NMN is yet another example of the inconsistent and mercurial way in which FDA chooses to both interpret DSHEA and use its limited resources to supposedly protect the public health. FDA has not articulated any risk to the safety of the public posed by NMN when marketed as a dietary ingredient or dietary supplement.”